Suction Valve (MAJ-1443); Air/Water Valve (MAJ-1444)

The Suction Valve MAJ-1443 and Air/Water Valve MAJ-1444 are reusable endoscope channel accessories designed for use with Olympus ultrasound endoscopes in gastrointestinal procedures. The suction valve removes fluids, debris, air from patients and water from balloons; the air/water valve delivers air to clean the objective lens, water for lens washing, and sterile water to fill the balloon.

Both devices are reusable (versus the single-use predicate), manually actuated valves with the same intended functions as the predicate. The suction valve has no patient-contacting components; the air/water valve has indirect patient-contacting components. They are compatible with specific Olympus ultrasound endoscopes and require manual cleaning, disinfection, and autoclaving for reprocessing.

Not stated in this summary.

The subject devices perform identical functions to the predicate device (suction control and air/water delivery during GI endoscopic procedures) and are compatible with the same endoscope platform. Although the subject devices are reusable rather than single-use, Olympus conducted performance bench testing (compatibility, flow rates, leakage, durability, and microbiological evaluation) demonstrating that reusability does not impact safety or effectiveness. The technological design is similar, and all tests passed predefined acceptance criteria, establishing substantial equivalence despite the single-use/reusable difference.